Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

KAI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Ketorolac Tromethamine; Drug: KAI-1678; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015235

KAI-1678-002

Details and patient eligibility

About

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologist (ASA) classification 1, 2, or 3
• total hip or total knee replacement
• pain on postoperative Day 1 at least 40 mm on 0-100 mm visual analog scale (VAS)

Exclusion criteria

• presence of contraindications to nonsteroidal anti-inflammatory (NSAID) treatment
• recent history of angina or myocardial infarction (MI)
• clinically significant abnormality on laboratory tests or electrocardiogram (ECG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

A2: KAI-1678

Active Comparator group

Description:

Test Drug

Treatment:

Drug: KAI-1678

A3: Ketorolac

Active Comparator group

Description:

Active Comparator

Treatment:

Drug: Ketorolac Tromethamine